- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03112343
Information and Communication Technology Based Centralized Clinical Trial Monitoring System for Insulin Dose Adjustment (ICT)
An Information and Communication Technology-based Centralized Clinical Trial to Determine the Efficacy and Safety of Insulin Dose Adjustment Education Based on a Smartphone Personal Health Record Application
This is a 24-week, open-label, randomized, multi-center trial conducted in three tertiary hospitals. There are three follow-up measures; at baseline, post-intervention at Week 12, and Week 24. Subjects are diagnosed as type 1 DM, type 2 DM, and/or post-transplant DM, and initiate or currently use insulin therapy. After the given education on insulin dose titration and prevention for hypoglycemia and 1 week of run-in period, subjects are randomized in a 1:1 ratio to either the ICT-based intervention group or the conventional intervention group. Subjects in conventional intervention group will save and send their health information to the server via the PHR app, whereas those in ICT-based intervention group have additional algorithm-based feedback messages. The health information includes levels of blood glucose, insulin dose, details on hypoglycemia, food diary, and number of steps. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.
This study is based upon work supported by the Ministry of Trade, Industry & Energy (MOTIE, Korea) under Industrial Technology Innovation Program (No. 10059066, 'Establishment of ICT Clinical Trial System and Foundation for Industrialization.")
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- age between 18-69 years
- diagnosis of T1DM, T2DM, and/or post-transplant DM (Post-transplant DM includes both diagnosed T1DM or T2DM before organ transplantation and first diagnosed DM after organ transplantation)
- initiation or current use of insulin therapy including once-daily basal insulin (including basal insulin only or basal insulin plus rapid-acting insulin), premixed insulin, or NPH)
- most recent hemoglobin A1c (HbA1c) ≥7.0% based on the National Glycohemoglobin Standardization Program (NGSP) at least 3 months prior to participation (recent HbA1c values measured <3 months prior to screening are permitted.)
- available to use smartphone and wireless internet
- Voluntarily write consent to participate in the trial
Exclusion criteria
- on insulin pump
- history of alcohol or drug abuse 1 year prior to participation
- history of psychological disorder (e.g., schizophrenia, depression, or bipolar disorder)
- history of severe visual or hearing impairment
- pregnant
- any condition, in the investigator's opinion, not suitable for enrollment eligibility.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ICT-based intervention
Subjects in the ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
|
ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
Subjects will save and send their health information to the server via the personal health record app
|
Placebo Comparator: Conventional intervention group
Subjects in the conventional intervention group will only save and send their health information to the server via the personal health record app
|
Subjects will save and send their health information to the server via the personal health record app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the proportion of patients who reach his/her optimal insulin dose within 12 weeks of enrolling in the study without severe hypoglycemia or unscheduled clinic visits.
Time Frame: Week 12
|
Reaching optimal insulin dose: A.For a patient who uses basal insulin only or basal insulin with pre-meal rapid-acting insulin once per day,1)3 or more fasting blood glucose(FBG) values in the morning within the target range(80-130mg/dL or 100-140 mg/dL) during Week12,2)no nocturnal(11pm-7am) or pre-breakfast hypoglycemia(<70mg/dL) during Week12,3)variation of basal insulin dose (the difference between the highest and lowest basal insulin dose) of <10% of mean total basal insulin dose during Week12.
B.For a patient who uses MDI at least twice per day, the criteria A plus 4)3 or more days in which correction dose premeal insulin is required less than 3times per day during the Week12,5) no daytime(7am-11pm) hypoglycemia during Week12.
C.For a patient who uses premixed insulin or NPH,1)3 or more FBG values in the morning and evening within the target range during Week 12,2) no nocturnal or pre-breakfast hypoglycemia during Week12
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
Time Frame: Week 24
|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 24
|
Week 24
|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
Time Frame: Week 12
|
the proportion of patients who reach HbA1c <7% without severe hypoglycemia (unrecoverable hypoglycemia without the help of others) at Week 12
|
Week 12
|
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
Time Frame: Week 12 and 24
|
mean fasting blood glucose values for three consecutive days prior to Week 12 and Week 24
|
Week 12 and 24
|
levels of HbA1c at Week 12 and Week 24
Time Frame: Week 12 and Week 24
|
levels of HbA1c at Week 12 and Week 24
|
Week 12 and Week 24
|
lipid profile at Week 12 and Week 24
Time Frame: Week 12 and 24
|
lipid profile at Week 12 and Week 24
|
Week 12 and 24
|
the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
Time Frame: Week 12 and Week 24
|
the proportion of patients having hypoglycemia (total, asymptomatic, daytime, nighttime, severe hypoglycemia, and coma/convulsions) at Week 12 and Week 24
|
Week 12 and Week 24
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the number of steps during Week 1-12 and Week 13-24
Time Frame: Week 12 and Week 24
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the number of steps during Week 1-12 and Week 13-24
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Week 12 and Week 24
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recorded exchange unit by food group
Time Frame: Week 12 and 24
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recorded exchange unit by food group (grains, meats and protein, fruits, vegetables, dairy, and fats and oils) in each breakfast, lunch, and dinner on 3-day food diary at Week 12 and 24
|
Week 12 and 24
|
daily insulin dose
Time Frame: Week 12 and Week 24
|
daily insulin dose at Week 12 and Week 24
|
Week 12 and Week 24
|
blood pressure
Time Frame: Week 12 and Week 24
|
blood pressure at Week 12 and Week 24
|
Week 12 and Week 24
|
body weight
Time Frame: Week 12 and Week 24
|
body weight at Week 12 and Week 24
|
Week 12 and Week 24
|
lean body mass
Time Frame: Week 12 and 24
|
lean body mass at Week 12 and Week 24
|
Week 12 and 24
|
fat mass
Time Frame: Week 12 and 24
|
fat mass at Week 12 and Week 24
|
Week 12 and 24
|
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring
Time Frame: Week 12 and 24
|
Satisfaction evaluation by questionnaire for ICT-based centralized clinical trial monitoring at Week 12 and 24
|
Week 12 and 24
|
Satisfaction evaluation by DTSQ
Time Frame: Week 12 and 24
|
Satisfaction evaluation by DTSQ at Week 12 and 24
|
Week 12 and 24
|
the number of telephone counselling by diabetes educators
Time Frame: Week 12 and 24
|
the number of telephone counselling by diabetes educators
|
Week 12 and 24
|
the number of self-monitoring blood glucose measurements
Time Frame: Week 12 and 24
|
the number of self-monitoring blood glucose measurements
|
Week 12 and 24
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Sang-Man Jin, MD PhD, Samsung Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-08-006-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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